FDA sets decision date for Pfizer's MenB candidate
|Dr. Emilio Emini, Pfizer's SVP of vaccine R&D|
Pfizer ($PFE) and Novartis ($NVS) are in a dead heat to become the first vaccinemaker to roll out a meningitis B vaccine for the U.S. market. But the New York pharma giant just became the first of the two to snag a decision date from the FDA, which says it will have an answer on Pfizer's candidate within the next 6 months.
Thursday, the agency accepted Pfizer's Biologics License Application for its MenB contender, dubbed rLP2086, granting it priority review designation. Along with it came a PDUFA action date of February 14, 2015.
"Both the acceptance of Pfizer's Biologics License Application today, and its Priority Review designation, are significant regulatory milestones that underscore the importance of our efforts to expedite the approval and subsequent availability of our meningococcal B vaccine for U.S. adolescents," Dr. Emilio Emini, Pfizer's SVP of vaccine R&D, said in a statement.
At one time, it looked like Novartis' rival jab, Bexsero, would beat rLP2086 to the regulatory finish line by a long shot. But impressive Phase II results showed that rLP2086 could safely spur the development of meningococcal disease-fighting antibodies in patients, convincing Pfizer to move ahead with its filing.
That doesn't mean Novartis' own PDUFA date is necessarily a long way off. Currently, the Swiss pharma is awaiting feedback from the FDA, a spokeswoman told FierceVaccines. But it filed its BLA the same day Pfizer did, meaning it could follow sooner rather than later.
In the meantime, as Pfizer waits for the FDA's verdict, it's working on bulking up its vaccines unit in other ways. Pfizer is "building on our world-leading Prevnar franchise, to expand the benefits of vaccines to more patients across ages and geographies," a spokeswoman told FierceVaccines. To that end, the company recently grabbed a CDC panel recommendation for universal use of the shot in adults over 65. And late last month, the New York-based drugmaker added to its marketed vaccines lineup, picking up a pair of shots from Baxter in a $635 million deal.
- read the release
Pfizer puts the heat on Novartis with FDA MenB filing
Pfizer prepares to file for approval with positive PhII MenB data
'Breakthrough' nod for Pfizer MenB candidate sets up showdown with Bexsero
Pfizer pins hopes on vaccine data to kick-start revenue growth
Pfizer details plans to expand vaccine portfolio beyond Prevnar